1. Field of the Invention
This invention is in the field of medical devices and methods, and more particularly, directed to the field of endoscopes, such as speculae, anoscopes and sigmoidoscopes, and the like, and their light sources, and the use of speculae and other endoscopic instruments with particular light sources for diagnosis of various abnormalities, as well as for regular examinations. This invention also relates to a new method for performing vaginal exams to greatly improve the accuracy of detecting various disorders, and new devices for performing the improved exams.
2. Art Background
As used herein the term speculoscopy refers to an endoscopic procedure involving a visually magnified examination of a body cavity or cavities employing a diffuse, internal, chemiluminescent light source. It is a special type of endoscopy, generally suited for vaginal exams, although it may be employed in the examination of any body cavity.
The use of an endoscope for various medical diagnostic procedures is well known in the art. Many different types of endoscopes are known for such diagnostic procedures, as well as for retraction during various surgical procedures, and one type of device is disclosed in my copending U.S. patent application Ser. No. 07/526,770.
This patent application discloses an endoscopic instrument, such as a speculum, comprising a housing and a chemiluminescent light source attached thereto. The light source is comprised of an elongated sealed tube made of transparent or translucent material and having disposed therewithin a chemiluminescent material. The chemiluminescent light source transmits a diffused source of light throughout the cavity being observed. The chemiluminescent light source is attached to the instrument body by an attachment means disposed along the longitudinal axis of the instrument body. This chemiluminescent light source, while not specified in the application, has been an orange/yellow, also called amber, light having a wavelength profile as shown in FIG. 10. This device has been on sale for several years.
The chemiluminescent light source, in addition to providing a portable source of illumination of the body cavity, does so without producing any heat which could damage, or at least be uncomfortable to, the tissue in the body cavity which is being observed with the endoscopic instrument or by use of the speculum. Moreover, there is no requirement for any electrical source such as a power cord or batteries. This device also disburses light throughout the cavity being observed, rather than focuses light at a specified location.
With respect to many of such endoscopes comprising the chemiluminescent light source, the entire instrument, including the light source, may be disposed of after use. For other instruments, which are not disposable, those instruments may be sterilized, and the chemiluminescent light source disposed of and then replaced, to obtain a completely sterile device.
In view of the fact that the chemiluminescent light source does not require any electricity, the endoscope does not have to be connected to or powered by any electrical source and can be stored for substantial periods of time without any loss of function because until the chemiluminescent light source is activated by the combination of the two chemiluminescent components, there is no loss of function. On the other hand, batteries which are used in the operation of standard electrical lights which are used in many prior art devices, can deteriorate in function even when not in use over a period of time, particularly under adverse conditions such as high heat and/or humidity. Thus, the present invention is particularly useful in primitive locations where relatively high temperature and heat may be prevalent and long periods of storage may be required before the invention is used as an endoscope or speculum. Of course, the present invention does have some anticipated shelf life and may, at times be somewhat temperature sensitive.
Currently, a standard gynecological exam or gyn exam comprises the use of a speculum, a visual examination of the interior cavity and related structures, palpation of the pelvic region and a pap smear. The visual examination is typically performed using a gooseneck lamp or even a flashlight without any use of magnification, although magnification is certainly available in the medical field in other areas, such as microsurgery. There are several disadvantages to the current procedure.
First, because a projecting light source is used, the ability to visualize abnormalities or areas of concern is diminished since there is not evenly disbursed lighting and there may be shadows or glare which distort the appearance of the area. Second, because an external light source is used, the same problems occur. Third, because the light source is incandescent, it gets hot and cannot be placed too close to the patient without burning or uncomfortably heating the area being examined, or the area adjacent thereto. Finally, and of some concern, the various peaks of the wavelengths of the light (generally white light) is not the most advantageous for viewing the various abnormalities to be detected. If the abnormalities are not detected visually, they may be detected by the Pap smear. However, there has been an increasing amount of controversy surrounding the Pap smear, regarding the quality of the sampling taken and consequently the accuracy of the results, which are typically performed by an outside laboratory, rather than by the doctor himself, or even his staff under his supervision. Consequently, the false negative rate for Pap smears (indicating nothing wrong, when there is a problem) has been shown to be approximately 30%).
If abnormalities are detected, the patient is brought in a second time for a more detailed examination using a colposcope. This device is a binocular microscope which is placed near the patient. A bright light, (blue/green filtered white incandescent light) is supplied. The operator looks through the eyepieces of the colposcope much like looking through field glasses. This procedure is performed with a vaginal speculum or similar device in place. Some of the colposcopes have camera attachments for still picture photography.
If abnormalities are detected, the physician washes the area with 3-5% acetic acid and then exams the tissue for whitened areas after treatment. The acetic acid whitens tissue which is thickened, such as cancer cells. The physician also looks for clusters of blood vessels which may indicate new growth such as cancer.
The effectiveness of this colposcopy procedure in detecting abnormalities is believed to be approximately 85%, and this effectiveness is due in part to the greater amount of experience which physicians who utilize this procedure generally have. It should be noted, however, that the colposcope is difficult to use because of its size, weight and complexity. Accordingly, it is not available in all medical facilities. It is also very expensive and not at all portable.
Because colposcopy is a specialized procedure, requiring advanced and comprehensive training on very complicated and expensive apparatus, colposcopy is typically only performed on patients who have had an abnormal screening procedure (i.e. Pap smears or other indications). Such systems have been shown to be useful in the confirmation of Pap test results, as well as in other diagnostic procedures. Various forms and variations of colposcopes are disclosed in U.S. Pat. Nos. 3,994,288, 4,134,637, 4,232,933, 4,652,103 and 4,905,670.
One prior art colposcope is described in Adair, U.S. Pat. No. 4,905,670, which discloses an apparatus which includes a vaginal speculum having a first fixed blade, a second blade mounted for pivotal movement toward and away from the fixed blade and spring means normally urging the second blade toward the fixed blade. The apparatus also includes a video camera mounted on one of the blades for viewing the cervix, means providing light to the cervix, means for focusing the camera on a selected site on the cervix and means for providing a signal from the camera to a video screen for viewing the cervix and identifying lesions thereon. The light providing means can include a light carrier on the track for providing light to the cervix. In addition, means is provided for selecting light for illumination of the cervix at any one of a range of light frequencies. This can be broad frequency light, monochromatic light or possibly even laser light for illumination. A particularly useful light frequency has been found to be from 200 nm through 1100 nm. A suitable means for stepping sequentially through the frequencies is a monochromator. The monochromator converts light from a light source to a single frequency at an output in the form of a rectangular slit. A light carrier is provided which includes a bundle of optical fibers having a first end in a form of a rectangular collar for receiving the output from the monochromator and a circular collar at the other end for directing a round column of light onto the cervix.
Regarding the speculae which have been used over the years, the following are representative of those having attachments and designs which are pertinent to the subject invention:
Casaneda U.S. Pat. No. 4,210,133 discloses a vaginal speculum having a microscope mounted thereon which has a light source for illumination and is longitudinally adjustable for focusing.
VanDerBel U.S. Pat. No. 4,597,383 discloses a vaginal speculum having optical fiber illumination means attached thereto.
Burgin U.S. Pat. No. 4,638,792 has an adjustable speculum with an incorporated light system.
Walsh U.S. Pat. No. 4,619,248 discloses a light attachment for a speculum.
Wider et al. U.S. Pat. No. 4,562,832 illustrates in FIG. 6 a fiberoptic light pipe installed in the lower jaw of the vaginal speculum.
Burgin U.S. Pat. No. 4,502,468 has an adjustable speculum with an incorporated lighting system.
Whitman U.S. Pat. No. 3,789,835 discloses an illuminating attachment for vaginal speculum.
Stafl U.S. Pat. No. 4,300,570 discloses a diagnostic method including projecting and magnifying an image of a cervix photographed by a device disposed on a speculum.
Walden et al. U.S. Pat. No. 3,037,505 discloses a speculum with a spray tube carried by a jaw of the speculum.
Tanikawa et al. U.S. Pat. No. 4,461,558 discloses an endoscopic photographing apparatus applicable to all types of endoscopes and uses therefor.
Toyota et al. U.S. Pat. No. 4,697,210 discloses an endoscope for observing the interior of a cavity in a human body with the image displayed on a TV screen.
The last two patents are representative of many observation techniques available for use with endoscopes.
The present invention overcomes the drawbacks of the prior art by providing an endoscopic examination and viewing system that is compact, portable, disposable, shadowless, economical and efficient. The present invention also comprises a method of detection of various cellular abnormalities which is quicker, easier, more economical, simpler, more compact, and which can be performed in an office setting without the use of prior art colposcopy equipment.